FDA approves biosimilar drug for rheumatoid arthritis
The U.S. Food and Drug Administration approved Amgen Inc’s biosimilar copy of Johnson & Johnson’s rheumatoid arthritis drug, Remicade, Reuters reports.
The biosimilar, Avsola, has the same chemical components, dosage form and strength as Remicade and would treat a range of autoimmune disorders.
The label for the treatment carries a boxed warning, FDA’s harshest, flagging risks of serious infections and malignancy, similar to that of Remicade’s.
Avsola was approved for all eligible indications of Remicade, including the treatment of bowel disease, Crohn’s disease and skin disorder plaque psoriasis, the agency said.
With the regulatory approval, Avsola joins the existing biosimilars to J&J’s drug, including Pfizer Inc’s 2017 approved Ixifi, Celltrion Inc’s Inflectra and Merck & Co and Samsung Bioepis Co Ltd’s Renflexis.